I – Context
Our concerns about what we call, figuratively, imprisonment and mastery of guilt in relation to the state’s civil liability goes back a long time. In 2012, we expressed our concerns in the context of the alert launched by the General Inspection of Health Activities concerning the monitoring of the question of medical error in the context of patient safety, in particular through the existence of risk management policies, like incident and adverse events reporting systems.
At the time we looked at, what we are now recovering for its instructive value concerning the reality in this area, a decision issued by the administrative court, still valid and applicable under the regime approved by Decree-Law No. 48 051, of November 21 of 1967, concerning the right to compensation for damages suffered by individuals during the delivery of healthcare, assessed, according to tradition, in light of the verification of the assumptions of civil liability based on an unlawful and wrongful act.
In particular, our attention was drawn to the decision on the issue by the aforementioned court in the area that has drawn more attention and, correspondingly, where more significant advances have been made in the last decades in the area of Healthcare: security in the delivery of healthcare.
In the context of a disappearance of a patient who, being hospitalized in an Emergency Unit of a hospital, is found dead, fifteen days later, at 1800 meters from the hospital in a vacant lot, the main question to be decided, in the present case, was whether, in this circumstances, the hospital’s officials and agents infringed any legal rule or general principle applicable or infringed any technical and common prudence rules which should be taken into account. On this issue, the court decided that there is no obligation for the hospital to control and/or prevent the patients from leaving the hospital’s emergency unit, thus denying the claim of the Authors in the legal action because the requirements of unlawfulness and guilt were not met.
The current state and scientific knowledge in healthcare have, as was already the case at the time, been raising the greatest concerns of several organizations about the existence of a series of risks and the occurrence of adverse events in the provision of healthcare.
The implementation of the liability principle and its traditional rationalization in the classic assessment of the occurrence of the conditions of an unlawful act, guilt, damage and causal link between the fact and the damage, with the action being rejected if one of these condition is not met, that is to say, in the in casu verification of the conditions of non-contractual civil liability based on an unlawful and wrongful act, they deserve to be re-evaluated for the effective protection of the healthcare services user’s rights in view of the known risks of their activity.
The purpose of this paper is to re-launch a reflection on the importance, in relation to the reparation system for damages caused by the delivery of healthcare, of the traditional model of guilt-based civil liability and of the changes that the objective production of damages to healthcare service users associated to its inherent risks requires in a framework of apparent imprisonment to aquiline civil liability.
II – The legal protection of citizens in relation to security in the delivery of healthcare
Healthcare safety has been the subject of several conceptualizations, which have been produced around the term Patient Safety, which refer to reducing the risk of unnecessary damage in the delivery of healthcare to an acceptable minimum. An acceptable minimum refers to the collective notion, in light of current knowledge, available resources and in the context in which healthcare was provided as opposed to the risk of non-treatment or other alternative treatment.
In the Portuguese legal system, the rights of healthcare service users are established, among others, in the Constitution of the Portuguese Republic, in the Basic Health Law, approved by Law no. 48/90 of 24 August, in the National Health Service Statute, approved by Decree-Law no. 11/93, of January 15, in the Legal Regime of Hospital Management, approved by Law no. 27/2002, of November 8 and Law15/2014, of March 21, and in the Charter of Rights of National Healthcare Service Users Access to Healthcare, approved by Ordinance no. 153/2017, of May 4.
The protection afforded by law in the area of healthcare safety derives, in particular, from the right to life (see article 24 of the Constitution of the Portuguese Republic), the right to physical and moral integrity (see article 25 of the Constitution of the Portuguese Republic) and the right to health protection (see article 64 of the Constitution of the Portuguese Republic). The articulation of these fundamental rights and their orientation towards the protection of human dignity require, as far as the State is concerned, the guarantee and protection of physical and biological existence (…) implies: (a) not being able to dispose of people’s lives, in any way whatsoever; (B) an obligation to protect people’s lives from attacks or threats by others; (C) the duty to abstain from actions or the use of means that create an unnecessary or disproportionate danger to people’s life, it’s also within the State’s power, to prohibit health institutions of performing degrading or human treatments that can attack or offend, the body or spirit, by physical or moral means, the individual sphere of its users and also require the State to refrain from any act detrimental to health and to promote a “high level of protection of human health”.
The binding to these fundamental rights dictates that the State should ensure that citizens who use healthcare services are able to reduce the risk of unnecessary damage related to healthcare to an acceptable minimum, that is to say to ensure that healthcare is provided in a secure environment.
At the infra-constitutional level, without disregarding the duties of vigilance of healthcare professionals and healthcare services, which also results in the right of users to benefit from the delivery of healthcare in safety, the recognition of which, as defended by some authors, leads to the extension of the scope of unlawfulness for civil liability purposes, the express provision of a right of healthcare service users only obtained support in the texts produced by the Administration.
Regarding the quality of healthcare, without prejudice to the right to create public healthcare services and for them to function in accordance with their legitimate interests, according to paragraph 2 of Base V, Basic Law on Health only states that healthcare service users are entitled to be treated with adequate means, humanely and promptly, with technical correction, privacy and respect (Basis XIV, paragraph 1 c)). The same provision came to be incorporated in Law no. 15/2014 of March 21, which article 4, paragraphs 2 and 3, consecrate the rights of healthcare service users to the delivery of the most adequate and technically correct healthcare and provided humanly and with respect to the user. Without ruling out the need to interpret these legal norms in a current and systematic manner, which leads to the claim that the right to quality and safe healthcare is included there, it’s clear that only Article 29 of the Charter of Rights of Healthcare Service User, prepared by the Health Regulatory Entity in June 2005, expressly states the right of healthcare service users to safety in the delivery of healthcare.
Comparing the two, we see that the French legal system provides a safeguard of security in the provision of healthcare as a person’s right. Article L. 1110-5 of the Code de la Santé Publique, approved by the Law of March 4, integrated in the chapter dedicated to the person’s rights determines that Toute personne a, compte tenu de son état de santé et l’ urgence des interventions que celui-ci requiert, le droit de recevoir les soins les plus appropriés et de bénéficier des thérapeutiques dont l’efficacité est reconue et qui garantissent la meilleure sécurité au regard des connaissances médicales avérées.
Keeping an eye on the developments at Community level, in particular in view of the adoption of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the exercise of patients’ rights in cross-border healthcare, that aims to define rules to facilitate access to safe and high-quality cross-border healthcare in the Union, the implementation of which was put into practice by Law No 52/2014 of 25 August, it’s necessary to consider the recognition by the Directive of several healthcare users rights, namely, by article 4 of the Directive, the right to have healthcare provided to them in accordance with the principle of access to good healthcare and in accordance with the established standard of quality and safety. Law no. 52/2014, of 25 August, followed this provision in Article 4, no. 1, and also laid down the duty of healthcare providers to provide information to the patient on the mechanisms of quality control and safety of the healthcare they provide [cf. paragraph b) of no.1 of Article 6].
Without prejudice to the absence of express legal provision, our opinion is that safety in the delivery of healthcare is a right of healthcare service users, which binds these services and professionals to their services, reflecting the duties and obligations of these services and professionals, within the scope of the legal relations established with the first.
III – The State’s civil liability and protection of citizens affected by adverse events in the delivery of healthcare
The fundamental law, which consecrates, on the one hand, the fundamental rights on which the right to safe healthcare is founded, also consecrates the principle of the responsibility of public authorities (State and other public entities) for damages caused for actions or omissions practiced in the exercise of their functions and, because of that exercise, prejudicial to the rights and interests of individuals.
As Professors Gomes Canotilho and Vital Moreira argue, although some doctrine maintains that the scope of the legal provision contained in article 22 of the Constitution of the Portuguese Republic is limited to liability for unlawful and culpable acts, or at least unlawful acts, the constitutional protection of the right to reparation of damages should be extended to those cases of “responsibility for risk” in which there is an infringement of rights, freedoms or guarantees or damages for individuals derived from actions or omissions by the public power.
In the pursuit of this right to reparation for losses caused by the exercise of public powers by the State and other Public Entities, the ordinary legislator has established various forms of civil liability related to the administrative function, namely the provision of healthcare by the institutions and services integrated in the National Healthcare Service.
The legislator first stated, in Article 7 and following, the Extra-contractual Civil Liability Regime of the State and other Public Entities, that civil liability is based on unlawful acts, that is, actions or omissions by officers, employees and agents that violate constitutional, legal or regulatory provisions or principles or that violate technical rules or objective duties of care and result in an offense of rights or interests legally protected (Article 9, no.1) or in the abnormal operation of the service .
The complexity of healthcare services and the multifactorial causality of the occurrence of adverse events, in the sense of an accidental, atypical, unintentional and avoidable event, contemplates situations of objective occurrence of damages to privates caused by those events that are not attributable to the performance of any healthcare service officer, employee or agent, in particular, because it’s not possible to identify the perpetrator or perpetrators of the facts that gave rise to it, thus frustrating the enforcement of civil liability, at least under this method.
In the case of civil liability based on an unlawful act, still without abandoning the demand for the verification of the guilt requirement, the legislator ruled about the situation where damage is attributable to an abnormal functioning of the service by focusing the assessment of guilt on the service, that is, in the verification that its organization or its operation, in the case, have objectively taken place with a standard of diligence lower than that which, due to the circumstances and average standards of result, would be required to the service to avoid the damages produced.
This will be, in fact, the form of tortious civil liability that provides, in the current legal framework, a greater protection to healthcare service users in terms of compensation for damages they suffer as a result of the occurrence of adverse events during healthcare delivery, whenever its delivery is associated with risks not attributable to any particular conduct.
The risk-based liability method, in defiance of the dominant tradition of guilt-based civil liability, would be, in theory, the one that would be more suitable to guarantee the protection of citizens’ rights for the compensation of damages produced within the scope of casual risk inherent to a healthcare service. The removal of this form of civil liability from any negative judgment relating to the act that caused the damage, based on the requirements of who creates a risk answers for its consequences or whoever has under their control a thing or an activity answers for the risks they involve, would allow it to be considered as the best guarantee to the right for compensation for unnecessary damages related to healthcare that, given current knowledge, available resources and in the context in which the healthcare is provided, are considered to be avoidable by healthcare services.
The risk-based administrative liability is, however, restricted to certain facts, that is to say, facts resulting in damages arising from activities, things or administrative services which are particularly dangerous (Article 11, no. 1 of the RCEEP ), in the sense of being potentially more damaging to goods than normal. The need that such a requirement is met from the perspective of such “fact”, in our view and in view of the restrictiveness of that qualification, constitutes an obstacle to its application so that justice and equality are served in the cases that concern us. All this is in crisis.
The national jurisprudence has gradually, although under an apparent reserve in relation to its qualification as a particularly dangerous activity, to recognize margins of danger in healthcare service.
Directive 2011/24 /EU also imposes an obligation on Member States to ensure that there is a professional liability insurance plan, or a similar guarantee or provision that is equivalent or comparable to its purpose and is adapted to the nature and to the extent of the risk, for treatments carried out on its territory (Article 4, no.2 paragraph d)). In other words, the Directive obliges the Member States to adopt a civil liability framework or a guarantee or provision intended for the same purposes, the compensation for damages suffered in the course of the delivery of healthcare, adapted to the nature and extent of the risk which, of course, cannot be exempt from being built in view of the risks inherent to the delivery of healthcare known at the present date nor impervious to the continuous developments in this field.
The evolution of healthcare sciences and the progressive knowledge of the risks that affect healthcare delivery, the principle of the rule of law, human dignity and justice and equality require a legal framework that protects the citizens’ rights and, in their objective occurrence, to be compensated for the damages suffered as a result of the risks associated with the delivery of healthcare without unjustified and disproportionate burdens.
The solution envisaged in France in the Code de la Santé Publique for the establishment of a right to compensation based on national solidarity in respect of the damage caused by a medical accident, of a iatrogenic affection or of a nosocomial infection is, if not an example, a potential model to be adopted at the national level, in an eventual and foreseeable revision of the state’s civil liability framework in the exercise of the function of providing healthcare.
IV – Conclusion
Both internally and externally, quality health care and insurances are imperative today, deserving the integration expressed in the catalogue of healthcare service users’ rights and the densification in terms of duties and obligations of professionals and services that develop their activity in the area of healthcare.
Their importance for the respect for human dignity and for the exercise of fundamental rights calls for legal systems to safeguard a more effective protection through legal mechanisms and institutes that promote social justice.
The developments that we have seen in the past decades in the field of healthcare sciences and the advances in the knowledge of the risks inherent to the activity of healthcare require a disruption with the tradition of guilt-based civil liability in healthcare and the demonstration that legal systems are keeping up with the developments in science, while maintaining, at least, equal guarantees of protection for citizens.
Marco Aurélio Constantino, advogado da BAS
Read the Portuguese version here.
